Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

Techni-Pharma

Status and phase: Completed; Phase 4

Conditions: Dyschesia

Treatments: Drug: Placebo suppository; Drug: Eductyl suppository

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910832

07-EDU-01

EudraCT N° : 2007-0003658-27

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female over 18 years
• Patients with dyschesia
• Prescription of rehabilitation for dyschesia

Exclusion criteria

• Rectal diseases
• Pain killers
• Pregnant women
• Breast feeding patients
• Non-compliant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 2 patient groups, including a placebo group

Eductyl suppository

Experimental group

Treatment:

Drug: Eductyl suppository

Placebo suppository

Placebo Comparator group

Treatment:

Drug: Placebo suppository